01 15N Plus Lubeck GmbH
02 1Vintage Pharmaceuticals-Charlotte
01 2BISMUTH SUBCITRATE POTASSIUM
01 1Canada
02 1U.S.A
01 2Active
01 2Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-09
Pay. Date : 2022-02-22
DMF Number : 30295
Submission : 2017-09-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-07
Pay. Date : 2014-06-13
DMF Number : 28358
Submission : 2014-06-11
Status : Active
Type : II
A Bismuth Subcitrate Potassium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bismuth Subcitrate Potassium, including repackagers and relabelers. The FDA regulates Bismuth Subcitrate Potassium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bismuth Subcitrate Potassium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Bismuth Subcitrate Potassium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bismuth Subcitrate Potassium supplier is an individual or a company that provides Bismuth Subcitrate Potassium active pharmaceutical ingredient (API) or Bismuth Subcitrate Potassium finished formulations upon request. The Bismuth Subcitrate Potassium suppliers may include Bismuth Subcitrate Potassium API manufacturers, exporters, distributors and traders.
click here to find a list of Bismuth Subcitrate Potassium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bismuth Subcitrate Potassium DMF (Drug Master File) is a document detailing the whole manufacturing process of Bismuth Subcitrate Potassium active pharmaceutical ingredient (API) in detail. Different forms of Bismuth Subcitrate Potassium DMFs exist exist since differing nations have different regulations, such as Bismuth Subcitrate Potassium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bismuth Subcitrate Potassium DMF submitted to regulatory agencies in the US is known as a USDMF. Bismuth Subcitrate Potassium USDMF includes data on Bismuth Subcitrate Potassium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bismuth Subcitrate Potassium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bismuth Subcitrate Potassium suppliers with USDMF on PharmaCompass.
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